ID

15903

Description

The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test. NCT00835770 Part: Hospitalization

Keywords

Versions (1)
  1. 6/18/16 6/18/16 -
Uploaded on

June 18, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

English

Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 forms  
Subject Identification
Description

Subject Identification

Number of Facility
Description

Site number

Data type

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Hospitalization List
Description

Hospitalization List

Event number
Description

Event number

Data type

integer

Event Term for Hospitalization
Description

Reason for Hospitalization

Data type

text

Alias
UMLS CUI [1]
C1830395
Date of Admission
Description

Date of Admission

Data type

date

Alias
UMLS CUI [1]
C1302393
Date of Discharge
Description

Date of Discharge

Data type

date

Alias
UMLS CUI [1]
C2361123
Primary reason for Hospitalization
Description

Select one reason for each hospitalization

Data type

integer

Alias
UMLS CUI [1]
C1830395
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Similar models

Hospitalization BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS) (ENDORSE) NCT00835770

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Subject Identification
Site number
Item
Number of Facility
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Item Group
Hospitalization List
Event number
Item
Event number
integer
Reason for Hospitalization
Item
Event Term for Hospitalization
text
C1830395 (UMLS CUI [1])
Date of Admission
Item
Date of Admission
date
C1302393 (UMLS CUI [1])
Date of Discharge
Item
Date of Discharge
date
C2361123 (UMLS CUI [1])
Item
Primary reason for Hospitalization
integer
C1830395 (UMLS CUI [1])
reason for Hospitalization
Code List
Primary reason for Hospitalization
CL Item
MS Relapse (1)
CL Item
Other MS related complicaton (2)
CL Item
Other (3)
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